NCT01339910|TerminatedPhase 3ResultsDMC
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Accrual terminated as recommended by the data and safety monitoring board.
A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (BMT CTN #0901)
Sponsor study identifier
Secondary identifiers
interventional
272
1 country
32
Study Start
June 2011
Actual (reported)Primary Completion
January 16, 2017
Actual (reported)Study Completion
October 16, 2017
Actual (reported)The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC) versus reduced intensity conditioning (RIC) regimens.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 16, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2011
Actual (reported)April 21, 2011
Actual (reported)June 2011
Actual (reported)January 16, 2017
Actual (reported)October 16, 2017
Actual (reported)May 30, 2018
Actual (reported)Percentage of Participants With Overall Survival (OS)
Overall survival is defined as survival of death from any cause.
18 months post-randomization
Percentage of Participants With Relapse-Free Survival (RFS)
18 months post-randomization
Percentage of Participants With Disease Relapse
18 months post-randomization
Percentage of Participants With Treatment-related Mortality
18 months post-randomization
Percentage of Participants With Neutrophil and Platelet Engraftment
Days 28 and 60 post-transplant
Number of Participants With Donor Cell Engraftment
Days 28 and 100 and 18 months post-transplant
One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.
One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.
(Flu/Bu) * Fludarabine: 30 mg/m\^2/day on Days -6 to -2 (total dose of 150 mg/m\^2) * Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4
(Flu/Mel) * Fludarabine: 30 mg/m\^2/day on Days -5 to -2 (total dose of 120 mg/m\^2) * Melphalan: 140 mg/m\^2 on Day -2
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Fludarabine and Busulfan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Fludarabine and Melphalan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Busulfan and Fludarabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Busulfan and Cyclophosphamide
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordTreatment and procedure
Cyclophosphamide and Total Body Irradiation
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordMayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
University of California, San Diego Medical Center
La Jolla, California, 92093, United States
University of Florida College of Medicine
Gainesville, Florida, 32610-0277, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Emory University
Atlanta, Georgia, 30322, United States
Blood and Marrow Transplant Program at Northside Hospital
Vardiman JW, Thiele J, Arber DA, Brunning RD, Borowitz MJ, Porwit A, Harris NL, Le Beau MM, Hellstrom-Lindberg E, Tefferi A, Bloomfield CD. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood. 2009 Jul 30;114(5):937-51. doi: 10.1182/blood-2009-03-209262. Epub 2009 Apr 8.
Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005 Oct 15;106(8):2912-9. doi: 10.1182/blood-2005-05-2004. Epub 2005 Jun 30.
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
272 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2011
First Posted
April 21, 2011
Study Start
June 2011
Actual (reported)Primary Completion
(Bu/Flu) * Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m\^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m\^2, respectively) on Days -5 to -2 * Fludarabine: 30 mg/m\^2/day on Days -5 to -2: Flu (total dose of 120 mg/m\^2)
(Bu/Cy) * Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m\^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m\^2, respectively) on Days -7 to -4 * Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)
(Cy/TBI) * TBI: 1200-1420 cGy on Days -7 to -4 * Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Atlanta, Georgia, 30342, United States
University of Kansas
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
DFCI, Brigham & Women's Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55095, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Jewish Hospital BMT Program
Cincinnati, Ohio, 45236, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106-5061, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Utah BMT/University of Utah Medical School
Salt Lake City, Utah, 84132, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792-5156, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53211, United States
Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.
Copelan E, Casper JT, Carter SL, van Burik JA, Hurd D, Mendizabal AM, Wagner JE, Yanovich S, Kernan NA. A scheme for defining cause of death and its application in the T cell depletion trial. Biol Blood Marrow Transplant. 2007 Dec;13(12):1469-76. doi: 10.1016/j.bbmt.2007.08.047.
Scott BL, Pasquini MC, Logan BR, Wu J, Devine SM, Porter DL, Maziarz RT, Warlick ED, Fernandez HF, Alyea EP, Hamadani M, Bashey A, Giralt S, Geller NL, Leifer E, Le-Rademacher J, Mendizabal AM, Horowitz MM, Deeg HJ, Horwitz ME. Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol. 2017 Apr 10;35(11):1154-1161. doi: 10.1200/JCO.2016.70.7091. Epub 2017 Feb 13.
January 16, 2017
Actual (reported)Study Completion
October 16, 2017
Actual (reported)Last Updated
January 4, 2023
Results First Posted
May 30, 2018
Record last verified: 2022-12
Findings will be published in a manuscript
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Source: ClinicalTrials.gov.
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